Breast cancer is one of the health threats most feared by women, and is the most common form of cancer in women. A key to treatment is early detection. For example, an annual mammogram is a method that has been used in hopes of early detection of breast cancer. One problem with mammography is that such an imaging technique can only find breast cancer once it has taken form. All too often, breast cancer is discovered at a stage that is too far advanced, when therapeutic options and survival rates are severely limited. As such, more sensitive and reliable methods and devices are needed to detect cancerous, pre-cancerous, and other cancer indicators of the breast at an early stage. Such methods and devices could significantly improve breast cancer survival. While breast cancer is most common among women, in rare instances the human male may also have occurrences of breast cancer.
Other methods of detecting breast cancer are based on the fact that a vast majority of instances of breast cancer begins in the lining of mammary ducts. Studies have shown that fluid within the mammary duct contains high levels of breast cancer markers, and that an estimated 80%-90% of all breast cancers occur within the intraductal epithelium of the mammary glands. Fluid within the breast ducts contains an assemblage and concentration of hormones, growth factors and other potential markers comparable to those secreted by, or acting upon, the surrounding cells of the alveolar-ductal system. Likewise, mammary fluid typically contains cells and cellular debris or products that can also be used in cytological or immunological assays.
A typical breast nipple contains about 8 to about 12 orifices that are external termini of the mammary ducts through which milk and other mammary fluid flow during lactation, for example. The orifices are each surrounded by a sphincter muscle which normally keeps the ducts closed. Application of pressure posterior to the periphery of the sphincter muscles can cause the muscles to open. Samples of mammary fluid and/or mammary duct cells can be collected for analysis by expressing the fluid in the mammary duct, or by utilizing a vacuum assist device to draw fluid from the mammary duct. Another way to obtain samples of the contents of a mammary duct is through ductal lavage.
In many instances, a clinician may desire to take samples from the same duct over a period of time. This requires that the clinician be able to find the same duct repeatedly. A difficulty, however, often arises in identifying the particular mammary duct terminating at a nipple orifice that is yielding the sample fluid because of the relatively small size and natural irregular surface of the nipple. The present invention fulfills this need.
Prior developments have included integration of a magnifying lens to a device to aid in identification of a discharging nipple. An example of such a device is disclosed by U.S. Pat. No. 6,328,709, issued to Hung et al. In practice such an approach, however, typically falls short of generating the desired results. For example, typical mammary duct examinations require a number of procedures requiring identification and location of a particular nipple orifice. As such, a physician typically utilizes a head-mounted magnifying glass, thereby making an integrated magnifying lens unnecessary. Devices, such as that disclosed in aforementioned U.S. Pat. No. 6,328,709, are also problematic for the further reason that nipple heights among patients can vary substantially. As such the particular focal length of a magnifying lens may not be suitable for the nipples to be examined. Moreover, by their nature, magnifying lenses cause distortion of the image viewed.
The present invention overcomes the problems encountered with the prior art and provides an improved device for viewing and identifying mammary duct orifices.